Rapid closing surgical closure device

ABSTRACT

A surgical or wound closure device utilizes a slide fastener for rapidly closing a surgical incision or wound with precise apposition of the sides of the incision. The surgical closure devices are configured for linear incisions, shaped incisions, such as used for wedge biopsy or excisional biopsy, and long incisions, such as used for laparotomy or surgical removal of redundant skin. The surgical closure device may be adhered to the patient&#39;s skin prior to making an incision and is subsequently used for closing the incision.

RELATED APPLICATIONS

This application is a continuation of PCT Application No.PCT/US2010/000430 (Attorney Docket No. 35383-706.601), filed May 3,2010, which claims the benefit of Provisional Application 61/243,423(Attorney Docket No. 35383-706.101), filed Sep. 17, 2009, the contentsof which are incorporated herein by reference in their entirety.

BACKGROUND

1. Field of the Invention

The present invention relates generally to surgical closure devices and,more particularly, to devices for rapidly closing a surgical incisionwith precise apposition of the sides of the incision. Additionalfeatures provide for injection of anesthetics or other drugs into oraround the surgical site, drainage of the surgical site, cutting guidesfor specially shaped incisions and controllable compression of theapposed edges for improved healing.

2. Description of the Background Art

A number of previous inventors have proposed surgical closure devicesthat utilize slide fasteners and the like for rapid closure of surgicalincisions or wounds. Examples of these devices include:

-   -   De Muth U.S. Pat. No. 2,012,755 Surgical Dressing    -   Howell U.S. Pat. No. 3,516,409 Slide fastener employing skin        closure appliances and techniques    -   Haverstock U.S. Pat. No. 3,863,640 Bandage construction    -   Haverstock U.S. Pat. No. 3,933,158 Skin closure means    -   Haverstock U.S. Pat. No. 4,114,624 Skin closure means    -   Sheehan U.S. Pat. No. 4,535,772 Skin closure device    -   Fukuda. U.S. Pat. No. 4,676,245 Interlocking surgical staple        assembly    -   Kaessmann U.S. Pat. No. 4,881,546 Wound-closure device and        method.    -   Will U.S. Pat. No. 4,905,694 Intracorporeal temporary wound        closure.    -   An Haack U.S. Pat. No. 5,377,695 Wound-closing strip

One slide fastener-type surgical closure device that has beencommercialized is the ETHIZIP Temporary Abdominal Wound Closure Devicefrom the Ethicon division of Johnson & Johnson. According to theinstructions for use, the ETHIZIP device must first be sewn into thefascia and peritoneum with sutures before the metal slider is used tojoin the two sides of the slide fastener together, therefore it is notsuitable as a rapid closure device. The ETHIZIP device is also notconfigured to be placed on the skin or other tissue prior to making anincision. Currently, surgical staples are usually employed when rapidclosure of a surgical incision is desired. Although they are fast andconvenient for the surgeon, surgical staples do not provide preciseapposition of the sides of the incision and the compression isexcessive, and unevenly distributed, which encourages scar formation.The staples themselves create local ischemia that causes extra scarring,in addition to the scar from the incision.

What is needed therefore, is a surgical closure device for rapidlyclosing a surgical incision with precise apposition of the sides of theincision and with controllable, uniform compression of the apposed edgesfor improved healing.

In addition, it is desirable to provide for injection of drugs, forexample anesthetics for pain control, into the wound or the surroundingtissue over a period of hours, days or longer.

SUMMARY OF THE INVENTION

In keeping with the foregoing discussion, the present invention takesthe form of a surgical closure device or wound closure device thatutilizes a slide fastener for rapid closure of a surgical incision orwound. In one particularly preferred method of use, the surgical closuredevice is adhered to the patient's skin prior to making an incision andis subsequently used for closing the incision.

BRIEF DESCRIPTION OF THE DRAWINGS

The advantages of the technology described above, together with furtheradvantages, may be better understood by referring to the followingdescription taken in conjunction with the accompanying drawings. Thedrawings are not necessarily to scale, emphasis instead generally beingplaced upon illustrating the principles of the technology.

FIG. 1 is a perspective drawing of the surgical closure device beingapplied to a patient's skin.

FIG. 2 shows the surgical closure device being used as a guide formaking an incision in the patient's skin.

FIG. 3 shows the surgical closure device in an open position for accessto the surgical incision.

FIG. 4 is a perspective view from the underside of the surgical closuredevice showing insertion of a drug injection manifold.

FIG. 5 is a perspective view from the upper side of the surgical closuredevice with the drug injection manifold in place. The binder and thefirst adhesion patch have been removed from the drawing to better showthe drug injection manifold.

FIG. 6 is an end view showing the cross-sectional details of thesurgical closure device.

FIG. 7 is a perspective drawing of a surgical closure device with aremovable appendage with a rail extension to park the binder during thesurgical procedure.

FIG. 8 is a perspective view from the underside of the surgical closuredevice of FIG. 7 showing the removable appendage.

FIG. 9 is a perspective drawing of a one-piece surgical closure devicewith dual binders and rail extensions.

FIG. 10 is a perspective view from the underside of the surgical closuredevice of FIG. 9 showing construction details of the ends of the device.

FIG. 11 shows insertion of a drug injection manifold into the surgicalclosure device of FIG. 9.

FIG. 12 shows the surgical closure device of FIG. 9 with the dualbinders closing around the drug injection manifold.

FIG. 13 shows the surgical closure device of FIG. 9 after removal of therail extensions.

FIG. 14 is a perspective view from the underside of the surgical closuredevice of FIG. 9 showing an optional feature of utility capillaries.

FIG. 15 shows another embodiment of the surgical closure device.

FIG. 16 is a perspective drawing of a surgical closure device for makinga shaped incision in a patient's skin.

FIG. 17 shows the surgical closure device of FIG. 16 with the shapedinsert removed.

FIG. 18 shows the surgical closure device of FIG. 16 with the binderbeing applied.

FIG. 19 shows the surgical closure device of FIG. 16 in a closedposition.

FIG. 20 shows another embodiment of a surgical closure device for makinga shaped incision in a patient's skin.

FIG. 21 shows a wire form for the surgical closure device of FIG. 20.

FIG. 22 shows a cross section of the rails of the surgical closuredevice of FIG. 20.

FIG. 23 shows a cross section of the rails of the surgical closuredevice of FIG. 20 with the wire form and binder in place. FIG. 24 showsthe surgical closure device of FIG. 20 in an open position.

FIG. 25 shows the surgical closure device of FIG. 20 in a closedposition.

FIG. 26 is a schematic drawing of a surgical closure device for applyinga continuous closing force to promote healing of a large skin incision.

FIGS. 27A, 27B and 27C show various configurations of tension membersfor use with the surgical closure device of FIG. 26.

FIG. 28 shows a surgical closure device for applying a unidirectionalclosing force.

FIG. 29 shows a surgical closure device for applying a radial closingforce.

FIG. 30 shows a surgical closure device with tension members in a randomor ad hoc configuration.

FIG. 31 shows a surgical closure device that allows application of thetension members in any desired pattern.

FIG. 32 is a detail drawing of one embodiment of the surgical closuredevice of FIG. 31.

FIG. 33 is a detail drawing of another embodiment of the surgicalclosure device of FIG. 31.

FIG. 34 shows a surgical closure device that uses independent strappatches for attachment of the tension members.

FIG. 35 shows three of the surgical closure devices of FIG. 34 appliedto a patient.

FIG. 36 shows a tension member that utilizes a constant force spring andan anchor member.

FIG. 37 shows a tension member with the constant force spring retracted.

FIG. 38 shows a tension member with the constant force spring extended.

FIG. 39 shows a multidirectional tension device that utilizes a springreel.

FIGS. 40A, 40B and 40C illustrate a surgical closure device configuredfor applying adjustable compression to an incision, shown in crosssection.

FIG. 41 illustrates a surgical closure device where the first and secondadhesion patches separate completely when in an open position. FIG. 42illustrates a surgical closure device where the first and secondadhesion patches are permanently attached at both ends.

FIG. 43 illustrates a surgical closure device with a binder having aY-shaped end to facilitate closure of the device.

FIG. 44 illustrates a surgical closure device with a binder configuredfor sequential closure of the device.

FIG. 45 illustrates a surgical closure device with a first and secondbinder configured for sequential closure of the device.

FIG. 46 is a cross section of a surgical closure device with a binderhaving a middle ridge for precise spacing of the first and second rails.

FIG. 47 is a cross section of a surgical closure device with a binderhaving a first and a second channel for applying adjustable compressionto an incision.

FIG. 48 is a cross section of a surgical closure device with a binderintegrated into one of the adhesion patches.

FIG. 49 is a perspective view of the underside of a surgical closuredevice having first, second and third drug injection manifolds.

FIG. 50 is an assembly drawing of a surgical closure device that usescompression to apply a continuous closing force to help promote closureand healing of the incision.

FIG. 51 shows the adhesive patch of the surgical closure device of FIG.50.

FIG. 52 shows an enlarged view of the expansion cells of the surgicalclosure device of FIG. 50.

FIG. 53 is a cutaway view showing one half of the surgical closuredevice of FIG. 50.

FIG. 54 is a cutaway view of the surgical closure device of FIG. 50 withthe retainer lifted off the device.

FIG. 55 is a perspective view of a dome-shaped surgical closure device.

FIGS. 56 and 57 show top and bottom exploded views of a surgical closuredevice with a skin cutting device. FIG. 58 is an assembly drawing of thesurgical closure device with a skin cutting device shown in FIGS. 56 and57.

FIG. 59 is a perspective view of a surgical closure device withsegmented rails.

FIG. 60 is an enlarged view of the segmented rails in the surgicalclosure device of FIG. 59.

FIG. 61 is a perspective view of a surgical closure device with lateralslots in the adhesion patch.

FIG. 62-65 illustrate a surgical closure device for making and closing ashaped incision in the patient's skin.

FIGS. 66A-66D show incision lines that are frequently used in surgicalremoval of redundant skin following successful bariatric surgery.

FIGS. 67-72 illustrate an embodiment of a surgical closure deviceconfigured for closing a large incision in a patient's skin.

FIGS. 73A-73E illustrate a surgical closure device with alignment cordsto assist in approximating the first rail and the second rail.

FIG. 74 is an enlarged view of the surgical closure device of FIGS.73A-73E in a closed position.

FIGS. 75-80 illustrate a low-profile surgical closure device using aC-shaped binder.

FIGS. 81-86 illustrate another low-profile surgical closure device usinga fork-shaped binder.

FIG. 87 illustrates an incision template for use with the surgicalclosure device of FIGS. 81-86.

FIG. 88 illustrates a fork-shaped binder with an inwardly convexcurvature to the tines.

FIG. 89 illustrates a fork-shaped binder for holding a surgical closuredevice in a partially open position.

FIG. 90 illustrates a fork-shaped binder configured to lift the tissueadjacent to the incision when the surgical closure device is in a closedposition.

FIG. 91 illustrates an adhesive protective cover with a tent-likestructure that can be applied along the incision line to raise thetissue adjacent to the incision.

FIGS. 92-94 illustrate a surgical closure device with two fork-shapedbinders that are inserted from opposite ends of the sleeves to hold thesurgical closure device in a closed position.

FIGS. 95-96 illustrate the surgical closure device of FIGS. 81-86 with adrug injection manifold.

FIG. 97 illustrates a drug injection manifold with drug injectionneedles or catheters that are curved alternately to the left and right.

FIGS. 98-99 illustrate an impermeable or hydrophobic protective coverthat is applied over the surgical closure device.

FIGS. 100-105 illustrate a surgical closure device for making andclosing a shaped incision in the patient's skin, such as a wedge biopsyincision.

FIGS. 106-107 illustrate a low-profile surgical closure device having aninternal binder.

FIGS. 108-109 illustrate an elongated surgical closure device that usesmodular fork-shaped binders to close an elongated incision.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 is a perspective drawing of a surgical closure device 100according to the present invention being applied to a patient's skin.Generally, the surgical closure device 100 includes a first adhesionpatch 102, a second adhesion patch 104 and a binder 106 that isconfigured to hold the first and second adhesion patch 102, 104 togetheras shown. The first adhesion patch 102 and the second adhesion patch 104are generally planar and are preferably constructed of a flexibleelastomeric material that is biocompatible for skin contact. Suitablematerials include, but are not limited to, natural rubber, polyurethane,silicone, etc. Optionally, the first and second adhesion patch 102, 104may be reinforced with fibers, a mesh or a woven or knitted textilefabric.

Optionally, the first and second adhesion patch 102, 104 may have pores,slits, mesh or openings through them to ventilate the patient's skinbelow the closure device 100. The skin contacting surfaces of the firstadhesion patch 102 and the second adhesion patch 104 have a medicallyacceptable skin adhesive 120 applied to them, preferably a contactadhesive that prior to use would be covered with a peel-away protectivefilm. Alternatively or in addition, the first adhesion patch 102 and thesecond adhesion patch 104 may be glued with an adhesive applied to thedevice and/or the skin (e.g. a medically acceptable cyanoacrylateadhesive), sutured or stapled to the skin.

In use, the first adhesion patch 102 and the second adhesion patch 104are arranged side-by-side with one another and, as shown in detail inFIG. 6, the adjacent edges are provided with a first rail 112 and asecond rail 114, respectively. The binder 106 includes a main channel122 that is sized to it over the first rail 112 and the second rail 114with a snug sliding fit. Preferably, the geometry of the first andsecond rail 112, 114 will provide a first and second undercut 132, 134for the inside edges 136, 138 of the main channel 122 to interlock with.This can be accomplished with many different geometries such as theexample shown where the first rail 112 and the second rail 114 areconfigured as half cylinders that fit together to form a completecylinder when joined together along a central parting line 124.Optionally, the first adhesion patch 102 and the second adhesion patch104 may also include a first supplemental rail 116 and a secondsupplemental rail 118, respectively, and the binder may include a firstsupplemental channel 126 and a second supplemental channel 128 that fitover the rails 116, 118 to provide additional attachment strength andstability to the surgical closure device 100 when in a closed position.Preferably, the first supplemental rail 116 and the second supplementalrail 118 also provide undercuts for the first supplemental channel 126and the second supplemental channel 128 to interlock with. Optionally,the first supplemental rail 116 and the second supplemental rail 118 mayalso be configured as cylinders, as in the example shown. The rails 112,116, 114, 118 are preferably molded of a polymer material, for exampleby casting, injection molding or extrusion, and may be formed integrallywith the first and second adhesion patch 102, 104, respectively.Alternatively, the rails 112, 116, 114, 118 may be overmolded with orassembled onto the first and second adhesion patch 102, 104. Optionally,one or more of the rails 112, 116, 114, 118 may be reinforced, forexample with reinforcing wires that run longitudinally through therails.

The binder 106 will preferably be molded of a polymer material, forexample by casting, injection molding or extrusion. Suitable materialsfor making the binder 106 include, but are not limited to, polyurethane,nylon, polypropylene, polycarbonate, etc. The binder 106 will haveenough circumferential strength in the wall of the main channel 122 tohold the first rail 112 and the second rail 114 firmly together when thesurgical closure device 100 is in the closed position. Optionally, thebinder 106 may be reinforced longitudinally or circumferentially aroundone or more of the channels. Preferably, the polymer material will havea low enough coefficient of friction that the binder 106 will slideeasily over the rails 112, 114, 116, 118.

The overall dimensions of the surgical closure device 100 will depend onthe surgical application, but, in general, the first and second adhesionpatch 102, 104 should have a length slightly longer than the length ofthe desired incision. Preferably, the binder 106 will also have a lengthslightly longer than the length of the desired incision. This isdesirable because it provides a very secure closure along the entirelength of the incision, particularly as compared to prior art devicesthat only use a small slider device to join the sides of a slidefastener together. FIG. 1 shows an embodiment where the binder 106 isapproximately the same length as the first and second adhesion patch102, 104, which is one optional configuration.

The surgical closure device 100 is adhered onto the patient's skin atthe desired incision site with the closure device 100 in a closedposition prior to making as incision, as shown in FIG. 1, which assuresthat the sides of the incision will be precisely apposed or aligned withone another when the closure device 100 is closed again after thesurgery. The binder 106 and the first and second adhesion patch 102, 104may be constructed with corresponding notches 146 and detents 144 tofurther assure that the sides of the incision will be precisely apposedwhen the closure device 100 is reclosed. Alternatively or in addition,similar notches and detents may be provided between the first and secondadhesion patch 102, 104 to assure that they align correctly whenever theclosure device 100 is closed.

FIG. 2 shows the surgical closure device 100 being used as a guide formaking an incision in the patient's skin. Alternatively or in addition,the surgical closure device 100 being used as a guide for opening and/ortreating the incision with coagulation or electrocautery. Optionally,the first rail 112 and/or the second rail 114 is constructed with aguide slot 140 along the parting line 124 for accepting a scalpel blade144 or the like for making a skin incision. The length of the guide slot140 can serve as an indication of the appropriate length of the incisionfor the closure device 100 that is being used. Optionally, the binder106 may be constructed with a slot or notch 142 on one or both ends thataligns the scalpel blade 144 with the guide slot 140 between the rails112, 114 for making the incision. The skin incision is madesimultaneously as the binder 106 is being slid off of the rails 112, 114with the notch 142 helping to hold the scalpel blade 144 at the correctdepth and angle for making the skin incision. This has the additionaladvantage that the binder 106 prevents the incision from being pulledopen by tension on the skin, which otherwise could cause the skin totear or the incision to wander. Alternatively, a scalpel blade 144 canbe mounted on a special blade holder device that is configured to slidealong the rails 112, 114 with the scalpel blade 144 at the correct depthand angle for making the skin incision. Otherwise, the incision can bemade after the binder 106 has been slid off of the rails 112, 114. FIG.3 shows the surgical closure device 100 in an open position for accessto the surgical incision. Once the initial skin incision is made, thefascia and muscular layers below the skin can be cut using knowntechniques to provide surgical access as appropriate for the surgicalprocedure being performed. The first adhesion patch 102 and the secondadhesion patch 104 and the tissue below them can be separated usingstandard surgical retractors to open the incision for surgical access.The strength of the adhesive 120 and the flexibility of the first andsecond adhesion patch 102, 104 help to keep the device 100 adhered tothe skin during these surgical manipulations.

After the surgical procedure has been completed and deeper tissues havebeen attached or closed using sutures, staples, glue or otherappropriate means, the first adhesion patch 102 and the second adhesionpatch 104 are brought closer together to approximate the sides of theincision. In many cases, it will be preferable to approximate the sidesof the incision with precisely the same alignment and position as beforethe incision was made. Then, the first rail 12 and the second rail 114are aligned and the binder 106 is slid over them to close the surgicalclosure device 100 with the sides of the incision precisely apposed toone another, similar to what is shown in FIG. 1.

The basic method of use can be summarized as follows: (1) adhere thesurgical closure device 100 to the skin in the closed position; (2)remove the binder 6 and make the incision; (3) open the incision andperform the surgical procedure; and (4) slide the binder 6 onto theclosure device 100 to close the incision. Variations of this methodutilizing optional features of the surgical closure device 100 aredescribed below.

FIG. 4 is a perspective view from the underside of the surgical closuredevice 100 showing insertion of a drug injection manifold 150. FIG. 5 isa perspective view from the upper side of the surgical closure device100 with the drug injection manifold 150 in place. The binder 106 andthe first adhesion patch 102 have been removed from the drawing tobetter show the drug injection manifold 150. The drug injection manifold150 is an important optional feature of the surgical closure device 100,which can be used in pain control, prevention of infection, andreduction of scarring and keloid formation. The drug injection manifold150 has a main tube 152 with a proximal connector 156, such as a Luerfitting, and a closed distal end 158. At least one, and preferablyseveral, drug injection needles 154 connect to the main tube 152 at aright angle. The hollow drug injection needles 154 may have blunt orsharp tips, depending how the drug injection manifold 150 is to be used.The main tube 152 and the drug injection needles 154 may be made from ametal, such as stainless steel, a flexible NiTi alloy or a polymer or acombination thereof. Microneedles can be fabricated using MEMStechnology or other microfabrication techniques.

In a particularly preferred embodiment of the surgical closure device100, the first and second rails 112, 114 are configured so that theyform a central lumen or cavity 110 into which the drug injectionmanifold 150 can be inserted. The cavity connects to several openings160 through which the drug injection needles 154 project into thepatient. In the embodiment shown, the openings 160 align with thecentral parting line 124 of the device. In addition, there may be one ormore larger drainage openings 162 along the central parting line 124 ofthe device. In the configuration shown, the drug injection manifold 150can be used in one or both of two modes. The drug injection manifold 150can be inserted into the cavity 110 between the first and second rails112, 114 prior to closure of the incision, so that an anesthetic, suchas lidocaine, can be continuously or intermittently injected into theincision to control pain in the incision and surrounding tissue duringhealing. Additional drugs, such as antibiotics, steroids or NS AIDS, mayalso be injected to control infection, to reduce inflammation and/or toreduce scar formation. In addition, cells and cell matrix such as stemcells can be injected too. When used in this mode, the drug injectionneedles 154 may have blunt tips because they can be inserted directlyinto the open incision. Alternatively, a drug injection manifold 150with sharpened drug injection needles 154 can be inserted into thecavity 110 between the first and second rails 112, 114 before adheringthe surgical closure device 100. The drug injection needles 154 willpierce the skin as the surgical closure device 100 is adhered to theskin. When used in this mode, the drug injection manifold 150 can beused to anesthetize the skin and surrounding tissue prior to making theincision. The incision can be made just adjacent to the drug injectionneedles 154. The drug injection manifold 150 can be also be used afterclosing the incision to control pain in the incision and surroundingtissue during healing.

In an alternative configuration, the cavity 110 and the openings 160 maybe offset from the central parting line 124 of the device. A druginjection manifold 150 with sharpened drug injection needles 154 can beinserted into the tissue beside the incision site before or after makingthe incision. A first and second drug injection manifold 150 withsharpened drug injection needles 154 can be inserted into the tissue onboth sides of the incision site before or after making the incision. Thefirst and second drug injection manifolds may be connected together in ahorseshoe or U-shaped configuration.

Another option is that the needles will be inserted in the middle butthe tip of the needles will be curved in such a way that when the twosides of the cut are approximated, the needles will penetrate the tissuefrom the sides and infiltrate the drug into it. Such a needle can bemade out of a nickel-titanium alloy as an example.

One or more drugs may be delivered by a syringe, a syringe pump, apressurized reservoir or a micropump connected to a reservoir. A drugpump may be energized with a resilient member, for example anickel-titanium spring, that presses against a drug reservoir. Manualforce to pressurize a pump or drug reservoir can also be provided by thepatient or a caregiver. One or more single dose squeezable ampoulesconnectable to an injection port on the device may be provided forfilling a drug reservoir within the device and/or for direct injectioninto or adjacent to the incision through the drug injection manifold.Optionally, the anesthetic dosage may be controlled by the patient.Optionally, a programmable pump may be used to control the rate anddosage of drug delivery.

FIG. 49 is a perspective view from the underside of a surgical closuredevice 100 showing additional options for the drug injection feature ofthe device. The surgical closure device 100 is shown with a first druginjection manifold 150 located at the center line of the device withdrug injection needles 154 to be inserted into the incision and secondand third drug injection manifolds 149, 151 located to the left and/orright side of the incision. The drug injection manifolds 149, 150, 151may all be connected to a single proximal connector 156, oralternatively each manifold may have its own separate proximalconnector. Optionally, the drug injection manifolds 149, 150, 151 may beconfigured as described above in connection with FIGS. 4 and 5.Alternatively however, one or more of the drug injection manifolds 149,150, 151 may be configured with more flexible plastic drug injectioncatheters 153 arranged coaxially around drug injection or tissuepiercing needles 154. For greater patient comfort, once a drug injectionmanifold has been inserted, the sharpened drug injection or tissuepiercing, needles 154 may be withdrawn, leaving only the plastic druginjection catheters 153 behind. Optionally, solid, sharpened stylets maybe used in place of the drug injection needles 154 in this configurationof the device. FIG. 49 shows the surgical closure device 100 after thedrug injection needles 154 of the second and third drug injectionmanifolds 149, 151 have been withdrawn, leaving the plastic druginjection catheters 153 in place. In one optional configuration, thesecond and third drug injection manifolds 149, 151 may be attached tothe first and second adhesion patches 102, 104 so that the druginjection needles 154 (and the optional catheters 153) are inserted intothe patient's tissue at the same time as the surgical closure device 100is applied to the skin. This configuration allows the area to beanesthetized through the second and third drug injection manifolds 149,151 prior to making the incision. Optionally, the first drug injectionmanifold 150 may be omitted in this configuration.

Alternatively or in addition, one or more drugs can be sprayed, brushed,dripped, poured or otherwise applied directly to the incision prior toclosure.

FIG. 7 is a perspective drawing of a surgical closure device 100 with aremovable appendage 170 with a rail extension 172 to park the binder 106during the surgical procedure. FIG. 8 is a perspective view from theunderside of the surgical closure device 100 of FIG. 7 showing theremovable appendage 170. The removable appendage 170 is attached at oneside of the surgical closure device 100 to both the first adhesion patch102 and the second adhesion patch 104. There is no adhesive on theunderside of the removable appendage 170. The first rail 112 and thesecond rail 114 extend onto the removable appendage 170 to form a railextension 172. In use, the binder 106 is slid off of the first rail 112and the second rail 114 and parked on the rail extension 172 of theremovable appendage 170 during the surgical procedure. This has a numberof advantages. First, it simplifies the step of closing the incisionbecause the binder 106 is already aligned with and mounted on the firstrail 112 and the second rail 114. Second, if the central parting line124 extends at least part way onto the removable appendage 170, it willallow the incision to be opened wide with a retractor without physicallydetaching the first adhesion patch 102 from the second adhesion patch104. Third, because the first adhesion patch 102 and the second adhesionpatch 104 are both attached to the removable appendage 170, it assuresthat the two sides of the incision will be precisely aligned with oneanother when the surgical closure device 100 is closed at the end of theprocedure. After the surgical procedure is completed, the binder 106 isslid back onto the first rail 112 and the second rail 114 to close theincision. The removable appendage 170 will preferably be made with tabs176 that can be used to grip the surgical closure device 100 to make iteasier to slide the binder 106 back onto the first and second rail 112,114. After the surgical closure device 100 is closed, the appendage 170may be cut off or may be torn off using perforations 174 that areoptionally provided.

FIG. 9 is a perspective drawing of a one-piece surgical closure device100 with dual binders 106, 107 and appendages 170, 171. FIG. 10 is aperspective view from the underside of the surgical closure device 100of FIG. 9 showing construction details of the ends of the device 100.This embodiment takes the previous concept one step further by adding asecond appendage 171 and a second rail extension 173 on the opposite endof the closure device 100 from the appendage 170 and the rail extension172 shown in FIGS. 7 and 8. There is no adhesive on the underside of theappendages 170, 171. Optionally, the appendages 170, 171 may includegripping tabs 176 and may have perforations 174 to make them removableas shown in FIGS. 7 and 8. As shown in FIG. 10, the first adhesion patch102 and the second adhesion patch 104 are joined together by the endportions 178 of the appendages 170, 171. The central parting line 124 ofthe device stops short of the end portions 178. The central parting line124 can be easily opened with surgical retractors, as shown by dashedlines 125, while keeping the one-piece device intact. In use, thebinders 106, 107 can be parked on the rail extensions 172, 173 of theappendages 170, 171 during the surgical procedure. Because the binders106, 107 are already aligned with and mounted on the first rail 112 andthe second rail 114, it is easier to close the surgical closure device100 after completion of the surgical procedure.

Optionally, the surgical closure device 100 of FIG. 9 may include a druginjection manifold 150 similar to that shown in FIGS. 4 and 5, exceptthat the proximal connector 156 is located in the center of the maintube 152 between two closed distal ends 158. FIG. 11 shows insertion ofa drug injection manifold into the surgical closure device 100 of FIG.9. The proximal connector 156 is positioned at a right angle to the druginjection needles 154 so that it will have a low profile when it snapsinto a slot 180 in the first rail 112.

FIG. 12 shows the surgical closure device 100 of FIG. 9 with the dualbinders 106, 107 closing around the proximal connector 156 of the druginjection manifold 150. The binders 106, 107 will preferably havenotches 182, 183 cut into their ends so that they will fit around theproximal connector 156 of the drug injection manifold 150 without a gapbetween them.

FIG. 13 shows the surgical closure device 100 of FIG. 9 after closure ofthe surgical incision. The appendages 170, 171 of the surgical closuredevice 100 have been removed after closing the surgical incision.Reference number 184 indicates a potential position on the device for anintegrated drug reservoir.

FIG. 14 is a perspective view from the underside of the surgical closuredevice 100 of FIG. 9 showing an optional feature of utility capillaries190 that may be included with any embodiment of the surgical closuredevice 100 described herein. The utility capillaries 190 may be used tohelp remove the surgical closure device 100 from the patient's skinafter the incision has healed sufficiently. A solvent, such as acetone,can be injected into the capillaries 190 to help dissolve and loosen theadhesive 120 that adheres the closure device 100 to the skin. A solventcan also be applied through pores or holes in the surface of thesurgical closure device 1100. Alternatively or in addition, pressurized,air or fluid can be infected into the capillaries 190 to help lift thesurgical closure device 100 off of the skin surface.

FIG. 15 shows another embodiment of the surgical closure device 100having additional rails for more stable and secure attachment of thebinder.

FIG. 16 is a perspective drawing of a surgical closure device 100 formaking and closing a shaped incision in a patient's skin. A simpledevice for making and closing a shaped incision in the patient's skinwill be useful in a number of common medical procedures including nodulebiopsy and removal of skin lesions and well as taking off skin excess inweight reduction procedures or cosmetic procedures. The surgical closuredevice 100 of FIG. 16 is quite similar to previously describedembodiments except that there is a nonlinear shaped opening 200 betweenthe first adhesion patch 102 and the second adhesion patch 104 thatdefines the shape of the incision. In one particularly preferredembodiment, the shaped opening 200 has the geometry of a rounded lozengeshape somewhat like the shape of an American football or a convex-convexlens. The first rail 112 and the second rail 114 follow the outline ofthe shaped opening 200. Preferably, the first and second adhesion patch102, 104 are joined together beyond the ends of the shaped opening 200.Optionally, the opening 200 may be biased toward an open position or aclosed position. A removable shaped insert 202 may be used to maintainthe shape of the opening 200 during attachment of the surgical closuredevice 100 to the patient's skin. This is particularly important if theshaped opening 200 is biased toward a closed position. The removableshaped insert 202 may be also used as a guide for a scalpel to cut theskin around the inside of the shaped opening 200 or the shaped insert202 may be removed before making the incision. FIG. 17 shows thesurgical closure device 100 of FIG. 16 with the shaped insert 202removed. The edges of the shaped opening 200 are preferably beveled atan angle (typically 45-90 degrees) to assist in holding a scalpel at theproper angle to cut out a wedge-shaped skin biopsy sample.

FIG. 18 shows the surgical closure device 100 of FIG. 16 with the binder106 being applied to close the incision. FIG. 19 shows the surgicalclosure device 100 of FIG. 16 in a closed position with the binder 106in place.

For removal of large skin lesions using the surgical closure device 100of FIG. 16, there may be a significant skin deficiency that must be madeup for so it may be desirable to expand the skin peripheral to theshaped opening 200. Small cuts may be made in a pattern in the skinunder and around the surgical closure device 100 so that the skinexpands in a lattice pattern that will heal to cover up the skindeficiency. A special device with small skin blades in the desiredpattern may be provided for performing this task. An inflatable balloonor other the like can be used to expand the skin prior to biopsy orexcision of a lesion in order to make up for the skin deficiency.

FIG. 20 shows another embodiment of a surgical closure device 100 formaking a shaped incision in a patient's skin. The surgical closuredevice 100 has a shaped opening 200 between the first adhesion patch 102and the second adhesion patch 104 that defines the shape of theincision. A removable shaped insert 202 may be used to maintain theshape of the opening 200 during attachment of the surgical closuredevice 100 to the patient's skin. The first rail 112 and the second rail114 follow the outline of the shaped opening 200.

A wire form 208, shown in FIG. 21, is provided for selectively biasingthe surgical closure device 100 toward the open position or the closedposition. The wire form 208 has a first leg 210 and a second leg 212joined together at one end by a first bend 214. The wire form 208 has anopen section 216 where the first leg 210 and the second leg 212 arecurved outward in a curve similar to the shaped opening 200 between thefirst adhesion patch 102 and the second adhesion patch 104 and a closedsection 218 where the first leg 210 and the second leg 212 are straight,parallel and close together. The wire form 208 is preferably formed froma metal wire, such as a stainless steel, cobalt-chromium ornickel-titanium alloy. Optionally, the first leg 210 and the second leg212 of the wire form 208 may have a low friction coating, such as PTFE.As shown in cross section in FIG. 22, a first lumen 204 extendslongitudinally through the first rail 112 and a second lumen 206 extendslongitudinally through the second rail 114 for receiving the first leg210 and the second leg 212 of the spine wire 208, respectively. FIG. 23shows a cross section of the first and second rails 112, 114 of thesurgical closure device 100 of FIG. 20 with the wire form 208 and thebinder 106 in place. After insertion through the first lumen 204 and thesecond lumen 206, the ends of the first leg 210 and the second leg 212are joined together, for example by welding, brazing or soldering, toform a second bend 220 located at the other end of the wire form 208, asshown in FIGS. 24 and 25. The first and second bends 214, 220 arepreferably shaped to form tabs or handles for easy gripping.

FIG. 24 shows the fully assembled surgical closure device 100 in an openposition. The wire form 208 is positioned so that the outwardly curved,open section 216 of the first leg 210 and the second leg 212 surroundsthe shaped opening 200, thereby biasing the device 100 toward the openposition. Optionally, the binder 106 may be attached to the wire form208 so that it is positioned around the closed section 218 of the wireform 208.

FIG. 25 shows the surgical closure device 100 of FIG. 24 in a closedposition. The wire form 208 has been slid longitudinally to a positionwhere the straight, closed section 218 of the first leg 210 and thesecond leg 212 surrounds the shaped opening 200, thereby biasing thedevice 100 toward the closed position. Because it is attached to thewire form 208, the binder 106 will automatically slide over the firstand second rails 112, 114 to secure the surgical closure device 100 inthe closed position. Alternatively, the binder 106 can be applied in aseparate step. As another alternative, the wire form 208 may beconstructed to be rigid enough to hold the surgical closure device 100in a closed position without the binder 106.

Optionally, the open section 216 of the wire form 208 may be trimmed ofor broken off after the surgical closure device 100 is in the closedposition. Optionally, a clip, staple or other fastener may be applied tothe wire form 208 prior to cutting to keep the first leg 210 and thesecond leg 212 from splaying apart once the open section 216 is removed.

In an alternative configuration, the wire form 208 may be made of amalleable material, such as annealed aluminum or copper, so that thesurgical closure device 100 can be manually formed into an open orclosed position. In addition, a malleable wire form 208 may be used toform the surgical closure device 100 to fit a nonlinear incision orpreexisting wound. FIG. 26 is a schematic drawing of a surgical closuredevice 230 for applying a continuous closing force to promote healing ofa large skin incision. After removal of a large biopsy sample or a largeskin lesion, there may be a significant skin deficit that needs to bemade up before complete healing of the incision can occur. A chronic orcontinuous closing force can help to promote closure and healing of theincision. A very pliable and flexible adhesion patch 234 with an opening236 in the middle is applied to the patient's skin surrounding theincision or lesion. The arrows 232 indicate how the closing force isapplied to the adhesion patch 234 around the opening 236 to promoteclosure of the incision.

FIGS. 27A, 27B and 27C show various configurations of tension members240 for applying a continuous closing force in the surgical closuredevice 230 of FIG. 26. FIG. 27A shows a tension member 240 that has anelongated body 248 with barbs 246 along the sides of the tension member240. A first end of the tension member 240 is attached to an anchormember 242 that is permanently or removably attached to the adhesionpatch 234. The elongated body 248 of the tension member 240 passesthrough a catch 244 that is also permanently or removably attached tothe adhesion patch 234. The catch 244 cooperates with the barbs 248along the sides of the tension member 240 to create a type of ratchetmechanism for selectively tightening the tension member 240. Theelongated body 248 of the tension member 240 is preferably made of anelastomeric material that will provide the desired range of tension. Thetension member 240 of FIG. 27B is similar to that of FIG. 27A, exceptthat the barbs 246 have been replaced with bumps or nubs 250 along thesides of the tension member 240. The tension member 240 of FIG. 27C haswaves or undulations 252 that interact with the catch 244 to create atension adjustment mechanism. The waves or undulations 252 also turn theelongated body 248 into a spring member, therefore the undulatedelongated body 248 can be constructed of a metal wire or a less flexiblepolymer as an alternative to the elastomeric material of the otherembodiments. The waves or undulations 252 may be planar or they may beformed in a helix or other three-dimensional shape.

FIG. 28 shows a surgical closure device 230 configured for applying aunidirectional closing force. A plurality of tension members 240 arearranged approximately parallel with one another across the opening 236of the adhesion patch 234. Tension in each of the tension members 240can be individually adjusted. FIG. 29 shows a surgical closure device230 configured for applying a radial closing force. A plurality oftension members 240 radiate from a common attachment point 254approximately over the center of the opening 236 in the adhesion patch234. Alternatively, a plurality of tension members 240 can be arrangedacross the diameter of the opening 236 in the adhesion patch 234.Tension in each of the tension members 240 can be individually adjusted.

FIG. 30 shows a surgical closure device 230 with tension members 240 ina random or ad hoc configuration. This arrangement is useful fortailoring the surgical closure device 230 to irregularly shapedincisions or lesions. The positions of each anchor member 242 and catch244, as well as the tension in each of the tension members 240, may beindividually adjustable.

FIG. 31 shows a surgical closure device 230 that allows application ofthe tension members 240 in any desired pattern. The flexible adhesionpatch 234 is constructed so that the tension members 240 can be easilyattached at any point on the surface of the patch 234.

FIG. 32 is a detail drawing of one embodiment of the surgical closuredevice 230 of FIG. 31 wherein the surface of the adhesion patch 234 isconstructed of a mesh material 256. A tension member 240 with barbs 250is being inserted through the mesh material 256 and tightened to applytension to the surgical closure device 230 in the desired pattern. Themesh material 256 performs the functions of the anchor member 242 and/orthe catch 244 described above.

FIG. 33 is a detail drawing of another embodiment of the surgicalclosure device 230 of FIG. 31 wherein the adhesion patch 234 isconstructed with a multiplicity of loops 258 on its surface. A tensionmember 240 is being inserted through the loops 258 and tightened toapply tension to the surgical closure device 230 in the desired pattern.The loops 258 perform the functions of the anchor member 242 and/or thecatch 244 described above.

FIG. 34 shows a surgical closure device 260 that uses independent strapadhesion patches 262, 264 for attachment of the tension members 240. Theanchor member 242 is attached to a first adhesion patch 262 and thecatch 244 is attached to a second adhesion patch 264. This allows evengreater flexibility for arranging the tension members 240 in any desiredpattern.

FIG. 35 shows three of the surgical closure devices 260 of FIG. 34applied to a patient. In this example, the tension members 240 arearranged approximately parallel to one another to provide aunidirectional closing force. Many other patterns are also possible.

FIG. 36 shows a tension member 240 that utilizes a constant force spring270 and an anchor member 242. The constant force spring 270 has theadvantage that it provides approximately constant force no matter whatthe displacement of the spring is. Thus, the tension in the tensionmember 240 would not need to be readjusted as the wound begins to closeand heal up.

FIG. 37 shows a tension member 240 with the constant force spring 270retracted. A hook 272 is attached at the end of the constant forcespring 270.

FIG. 38 shows the tension member 240 with the constant force spring 270extended. The hook 272 is hooked through a loop 274, which may beattached to an anchor member or attached directly to an adhesion patch.

FIG. 39 shows a multidirectional tension device 280 that utilizes aspring reel 282. A multiplicity of radial tension members 284 extendradially from the spring reel 282 and connect to a like number of anchormembers 286.

In some cases it is advantageous to apply a controlled amount ofcompression to an incision after closure in order to encourage healing.FIGS. 40A, 40B and 40C illustrate a surgical closure device 100configured for applying adjustable compression to an incision. FIG. 40 Ashows a cross section of the surgical closure device 100 applied to apatient's skin. The surgical closure device 100 includes a firstadhesion patch 102, a second adhesion patch 104 and a firstchannel-shaped binder 106 that is configured to slide over the first andsecond track or rail 112, 114 to hold the first and second adhesionpatch 102, 104 together with a controlled-width gap 103 in between.

An incision is made between the first adhesion patch 102 and secondadhesion patch 104 and the incision is opened for performing a surgicaloperation, as shown in FIG. 40B. It should be noted that the edges ofthe incision extend past the edges of the first and second rails 112,114.

FIG. 40C shows the incision after closure with the surgical closuredevice 100. A second channel-shaped binder 107 has been slid over thefirst and second rails 112, 114 to hold the first and second adhesionpatch 102, 104 together. The second channel-shaped binder 107 has achannel width that is less than the channel width of the firstchannel-shaped binder 106, which creates a controlled amount ofcompression at the incision line.

FIG. 41 illustrates a surgical closure device 100 where the first andsecond adhesion patches 102, 104 separate completely when in an openposition. This configuration is advantageous when a very large surgicalaccess is required for performing an operation. Markings, detents orother alignment mechanisms would be included to assure proper alignmentand apposition of the incision during closure.

FIG. 42 illustrates a surgical closure device 100 where the first andsecond adhesion patches 102, 104 are permanently attached at both ends.This configuration has the advantage that the incision will beautomatically aligned in proper apposition when the incision is closed.Alternatively, just one end of the first and second adhesion patches102, 104 can be permanently attached.

FIG. 43 illustrates a surgical closure device 100 with a binder 106having a Y-shaped end 109 to facilitate closure of the device. Thetapered entry of the Y-shaped end 109 on the binder 106 reduces theforce required for applying the binder 106 to close the incision.

FIG. 44 illustrates a surgical closure device 100 with a binder 111configured for sequential closure of the device. This configurationfacilitates the method described above in FIGS. 40A, 40B and 40C byintegrating the first binder 106 and the second binder 107 into a singlecomponent. Optionally, the binder 111 may have a tapered Y-shaped end109 as in the embodiment previously described. After the surgicaloperation is completed, the incision is closed by sliding the first partof the binder 113 over the first and second rails 112, 114, then slidingthe second, narrower part of the binder 115 over the first and secondrails 112, 114. The second, narrower part of the binder 115 may beconfigured to provide a. controlled amount of compression to theincision after closure.

FIG. 45 illustrates a surgical closure device 100 with a first andsecond binder 117, 119 configured for sequential closure of the device.The second binder 119 is narrower than the first binder 117. Thesurgical closure device 100 is closed sequentially by sliding the firstbinder 117 over the first and second rails 112, 114 from one end, thensliding the second, narrower binder 119 over the first and second rails112, 114 from the opposite end while backing the first binder 117 off.The advantage of sequential closing is reduced force and shear byclosing the surgical closure device 100 in a stepwise fashion. Multiplesteps may be used, optionally including binders with channels wider eventhan the first binder.

FIG. 46 is a cross section of a surgical closure device 100 with abinder 106 having a middle ridge 101 for precise spacing of the firstand second rails 112, 114. This configuration is advantageous forperforming the method described above in FIGS. 40A, 40B and 40C becauseit holds the first and second rails 112, 114 in careful alignment with acontrolled gap 103 in between.

FIG. 47 is a cross section of a surgical closure device 100 with abinder 106 having a first channel 121 and a narrower, second channel 123for applying adjustable compression to an incision. This configurationis advantageous for performing the method described above in FIGS. 40A,40B and 40C. The surgical closure device 100 can be initially applied tothe patient with the first channel 121 positioned over the first andsecond rails 112, 114. After the surgery is completed, the binder 106can be reapplied with the narrower, second channel 123 positioned overthe first and second rails 112, 114 to apply a controlled amount ofcompression to the incision.

FIG. 48 is a cross section of a surgical closure device 100 with abinder 106 integrated into one of the adhesion patches. Like thepreviously described embodiment, the binder 106 has a first channel 121and a narrower, second channel 123 for applying adjustable compressionto an incision. Multiple widths of channels are also possible. Closureof the surgical closure device 100 requires a slight lifting of thebinder 106 to place it over the single rail 114 on the opposite side.

FIGS. 50-54 illustrate an embodiment of the surgical closure device 300that uses compression, rather than tension, to apply a chronic orcontinuous closing force to help promote closure and healing of theincision. This is particularly useful for large incisions and/orincisions where a portion of the skin and tissue has been removed, forexample a nodule biopsy. FIG. 50 is an assembly drawing of the surgicalclosure device 300. The surgical closure device 300 has two main parts:an adhesive patch 302 that attaches to the patient's skin and a retainer304 that is used to hold the adhesive patch 302 in a compressed statewhile it is being applied to the patient's skin.

The adhesive patch 302, which is shown by itself in FIG. 51, has acentral opening 306 and a peripheral ring 308. The central opening 306may be lozenge shaped, as in the example shown, or it may be circular,oval or another desired shape. The adhesive patch 302 surrounding thecentral opening 306 is made from a flexible, elastic material, whereasthe peripheral ring 308 is made from a material that has a highertensile strength in order to resist expansion. Between the centralopening 306 and the peripheral ring 308, the surgical closure device 300has a grid 312, 314 of expansion cells 310 attached to the adhesivepatch 302. The expansion cells 310 in their natural state have atendency to expand, however because they are constrained by theperipheral ring 308, the expansion of the cells 310 causes the centralopening 306 to close. For a lozenge-shaped central opening 306, as inthe example shown, it is advantageous to arrange the grid of expansioncells 310 in two sections 312, 314, one on either side of the opening306, so that the inward expansion of the expansion cells 310 will be inthe direction of the arrows 316.

FIG. 52 shows an enlarged view of an exemplary construction of theexpansion cells 310. A plurality of circumferentially-oriented arcuateribs 318 are attached to the adhesive patch 302 on both sides of theopening 306. Positioned between the ribs 318 are a plurality ofcompression spring members 320, which are biased to push apart theadjacent ribs 318. Since the peripheral ring 308 resists expansion, thenet effect of the compression spring members 320 is to urge the centralopening 306 toward a closed position, as indicated by the arrow 316. Thecompression spring members 320 may be metal compression springs, e.g.stainless steel or a nickel-titanium alloy, elastomeric compressionspring members, e.g. rubber, neoprene, Santoprene, ethylene vinylacetate, etc. or resilient foam compression spring members made from anelastomer or other resilient polymer. FIG. 52 shows just one of manypossible configurations for the expansion cells 310.

FIG. 53 is a cutaway view showing one half of the surgical closuredevice 300 with the retainer 304 assembled to the adhesive patch 302.The retainer 304 has a plurality of grooves 322 that interlock with thearcuate ribs 318 on the adhesive patch 302 to hold the adhesive patch302 in an expanded position with the compression spring members 320 in acompressed state. The retainer 304 is preferably molded from a polymermaterial that is stiff enough to resist the combined force of thecompression spring members 320.

The assembled surgical closure device 300, as shown in FIG. 50, isadhered to the patient's skin with the central opening 306 positionedaround the intended incision site. The inner edge of the retainer 304may be used as a guide for cutting a wedge-shaped biopsy sample orportion of tissue with a lesion to be removed. When it is desired toclose the incision, the retainer 304 is lifted off of the adhesive patch302, as shown in the cutaway view in FIG. 54, leaving the adhesive patch302 adhered to the skin, as shown in FIG. 51. The ribs 318 on theadhesive patch 302 are no longer constrained by the grooves 322 on theretainer 304, so the compression spring members 320 will urge thecentral opening 306 toward a closed position.

In one optional configuration of the surgical closure device 300, thecompression spring members 320 and/or the adhesive patch 302 may be madeof a viscoelastic material that slowly urges the central opening 306toward a closed position. Optionally, the viscoelastic material may beactivated by the patient's body heat.

FIG. 55 shows an optional feature that may be used with the surgicalclosure device 300 of FIGS. 50-54 or with any embodiment of the surgicalclosure device described herein. The surgical closure device 300 isconfigured with a non-planar or three-dimensional contour for fitting toa body part. In the example shown, the surgical closure device 300 isshaped like a dome for a better fit on a patient's scalp or otherconvexly curved portion of the body. Other configurations are alsopossible.

FIGS. 56-58 show another optional feature that may be used with thesurgical closure device 300 of FIGS. 50-54 or with any embodiment of thesurgical closure device described herein. The surgical closure device300 includes a skin cutting device 330 having a multiplicity of cutterblades 332 attached to a handle 334. FIGS. 56 and 57 show top and bottomexploded views of the surgical closure device 300 with the skin cuttingdevice 330. The skin cutting device 330 fits over the top of thesurgical closure device 300 with the cutter blades 332 extending throughslots in the adhesive patch 302 and the retainer 304. The sharpened ends336 of the cutter blades 332 extend a short distance past the surface ofthe adhesive patch 302, as shown in the assembly drawing of FIG. 58, sothat they can cut approximately 1-2 mm deep into the skin. Preferably,the cutter blades 332 are arranged so that they will cut the skin in amesh pattern around the incision so that it can expand to make up theskin deficit created by removing a portion of the skin and underlyingtissue. The small cuts will heel more quickly and with less scarringthan the large incision where a lesion has been removed. The skincutting device 330 is removed after the skin has been perforated.

The skin cutting device 330 may be applied to the skin at the same timeas the adhesive patch 302 and the retainer 304 or alternatively, theskin cutting device 330 may be applied after the adhesive patch 302 andthe retainer 304 have already been adhered to the skin. In anotheralternative configuration, the cutter blades 332 may be integrated intothe retainer 304 so that the cutter blades 332 are applied to the skinat the same time that the surgical closure device 300 is adhered to thepatient.

FIGS. 59 and 60 illustrate an optional feature that can be used with anyof the embodiments of the surgical closure device described herein. FIG.59 is a perspective view of a surgical closure device 340 with segmentedrails 342, 344 that facilitate retraction of the incision for improvedsurgical access. Each of the rails 342, 344 is constructed with aplurality of segments 346 that are linked together by an elastic cord348, or the like. When the incision and the surgical closure device 340are subjected to retraction threes, for example using one or moresurgical retractors, the segments 346 separate, forming gaps 350 betweenthe segments 346 as shown in FIG. 59. FIG. 60 is an enlarged view of thesegmented rails 342, 344 with the segments 346 separated and the elasticcord 348 visible through gaps 350. The elasticity of the adhesion patch352 allows it to expand as the incision is retracted.

When the retraction forces are released, the elastic cord 348 pulls thesegmented rails 342, 344 back to their normal continuous configuration,similar to the configuration shown in FIG. 17. When it is time to closethe surgical incision, a binder 106 may be applied, as shown in FIGS. 18and 19.

FIG. 61 show another optional feature that can be used with any of theembodiments of the surgical closure device described herein, includingthe embodiment shown in FIGS. 59 and 60. FIG. 61 is a perspective viewof a surgical closure device 360 with lateral slots 362 in the adhesionpatch 364. The lateral slots 362 allow the adhesion patch 364 to expandwhen a retraction force is applied. The lateral slots 362 also allow theadhesion patch 364 to conform to the closed position of the surgicalclosure device, as shown in FIG. 19. Because of the lateral slots 362,less flexibility or deformation of the adhesion patch 364 material isrequired to accommodate the changes in shape during retraction orclosure of the surgical closure device 360.

Another optional feature that can be used with any of the embodiments ofthe surgical closure device described herein is to construct thesurgical closure device 100 with one or more heat exchanger passageswithin the first and second adhesion patches 102, 104 for circulatingcold water or another heat exchange fluid to help control pain andinflammation as the incision heals. The heat exchanger passages may belaid out in a serpentine pattern or other configuration to improve heatexchange efficiency. The surgical closure device 100 may have ports forconnecting the heat exchanger passages to an external pump.Alternatively, other means of heat exchange may be used in conjunctionwith the surgical closure device 100 to raise or lower the temperature,at the incision site.

FIGS. 62-65 illustrate another embodiment of a surgical closure device400 that is configured for making and subsequently closing a shapedincision in the patient's skin, for example a wedge biopsy incision. Thesurgical closure device 400 is similar in many respects to theembodiment of FIG. 16. There is a nonlinear shaped opening 408 betweenthe first adhesion patch 402 and the second adhesion patch 404 thatdefines the shape of the incision in one particularly preferredembodiment, the shaped opening 408 has the geometry of an ellipse or arounded lozenge shape somewhat like the shape of an American football ora convex-convex lens. The first rail 412 and the second rail 414 followthe outline of the shaped opening 408. Preferably, the first and secondadhesion patches 402, 404 are joined together beyond the ends of theshaped opening 408. The first adhesion patch 402, the second adhesionpatch 404, the first rail 412 and the second rail 414 are made offlexible materials that allow the shaped opening 408 to move from anopen position to a closed position. Optionally, the shaped opening 408may be biased toward the open position or the closed position.

The surgical closure device 400 has two separate binders, an open binder406 shown in FIG. 62 and a closed binder 410 shown in FIG. 65. The openbinder 406 has two channels 416, 418 on the underside that follow thecontours of a shaped opening 420 similar in shape to the opening 408 onthe device 400 between the first adhesion patch 402 and the secondadhesion patch 404. Preferably, an inner edge 422 of the shaped opening420 in the open binder 406 is beveled at an angle (typically 45-90degrees) to provide a cutting guide for a scalpel 424 when making awedge biopsy incision. The open binder 406 is preferably made of amaterial, such as a polymer and/or metal, that is more rigid than theadhesion patches 402, 404 and the rails 412, 414. When the open binder406 is attached to the surgical closure device 400, the channels 416,418 engage the first r it 412 and the second rail 414 and hold theshaped opening 408 of the device 400 in an open position, as shown inFIG. 62. For the convenience of the medical practitioner, the surgicalclosure device 400 is preferably supplied in a sterile package with theopen binder 406 already attached. The closed binder 410 has two channels426, 428 on the underside that are substantially straight and parallelto one another. The closed binder 410 is preferably made of a material,such as a polymer and/or metal, that is more rigid than the adhesionpatches 402, 404 and the rails 412, 414. When the closed binder 410 isattached to the surgical closure device 400, the channels 426, 428engage the first rail 412 and. the second rail 414 and hold the shapedopening 408 of the device 400 in a closed position, as shown in FIG. 65.

In use, the first adhesion patch 402 and the second adhesion patch 404of the surgical closure device 400, with the open binder 406 attached,are adhered to the patient's skin with the shaped openings 408, 420positioned around a suspected lesion, as shown in FIG. 62. An incisionis made with a scalpel 424 or other cutting instrument, using thebeveled inner edge 422 of the shaped opening 420 in the open binder 406as a cutting guide, as shown in FIG. 63. The open binder 406 provides anadditional benefit in that it protects the edges of the surgical closuredevice 400 adjacent to the shaped opening 408 from being accidentallycut during the incision step. The excised portion of tissue is removed,as shown in FIG. 64, and the open binder 406 is removed by lifting itoff of the rails 412, 414. The closed binder 410 is attached to thesurgical closure device 400 by sliding the channels 426, 428 over therails 412, 414 to close the shaped opening 408 and incision in the skin,as shown in FIG. 65. Optionally, the device 400 may be configured toapply a desired amount of compression to the incision when the closedbinder 410 is attached in order to promote healing.

FIGS. 67-71 illustrate an embodiment of a surgical closure device 440that is configured for closing a large incision in a patient's skin. Oneexample of a procedure that would benefit from the use of such a deviceis the removal of redundant skin following successful bariatric surgery.Over 200,000 bariatric surgeries are currently performed each year andthe number is growing. Removal of redundant skin is a very timeconsuming procedure with approximately 2000 stitches in predictableplaces over straight lines guided by anatomical landmarks. To make it goquicker, this procedure is typically performed by a team of surgeons.FIGS. 66A-66D show the incision lines that are frequently used insurgical removal of redundant skin.

FIG. 67 shows the surgical closure device 440 in an open position. Thesurgical closure device 440 may be a single device that will surroundthe entire circumference of the patient or, alternatively, the devicemay be modular and made up of either separate or interconnectedsegments. The surgical closure device 440 has a first rail 442 and asecond rail 444 with a contact adhesive backing for adhering them to thepatient's skin. In one preferred embodiment, the first rail 442 and thesecond rail 444 are as long as or slightly longer than the length of theincision. In the case of redundant skin removal after bariatric surgery,the first rail 442 and the second rail 444 may be long enough tocompletely encircle the patient. Alternatively, the first rail 442 andthe second rail 444 may be in shorter segments that can be adhered tothe patient's skin and joined end-to-end when closing the incision.Optionally, a first end of the first rail 442 and the second rail 444may be permanently joined together to facilitate closing the device.

FIG. 68 shows the surgical closure device 440 of FIG. 67 in an openposition and adhered to a patient's abdomen. The first rail 442 and thesecond rail 444 are placed along the intended incision lines with theexcess skin to be removed positioned between the first rail 442 and thesecond rail 444. FIG. 69 shows the patient with the redundant skin andfascia excised. Small margins of fascia are left for reattachment usingconventional suture methods.

FIG. 70 shows the surgical closure device 440 in a partially closedposition with the first rail 442 and the second rail 444 approximated toone another so that the edges of the skin will be properly approximated.A binder 446 has been started on the first end of the first rail 442 andthe second rail 444. FIG. 71 shows the surgical closure device 440 onthe patient's abdomen in the partially closed position.

FIG. 72 shows the surgical closure device 440 on the patient's abdomenin a closed position. The binder 446 has been slid onto the first rail442 and the second rail 444. Optionally, the excess length of the first442 and the second rail 444 may be removed.

FIGS. 73A-73E illustrate an optional feature that may be combined withthe surgical closure device 440 of FIGS. 67-72 or any of the othersurgical closure devices described herein. FIG. 73A shows short samplesections of the first rail 442 and the second rail 444 adhered to thepatient's skin. After the excess tissue has been excised, alignmentcords 448 are inserted through premade holes 450 in the first rail 442and the second rail 444. Then, the alignment cords 448 are pulled toapproximate the first rail 442 and the second rail 444 to one another.Optionally, the alignment cords 448 may have barbs, ratchet teeth orother features to lock the first, rail 442 and the second rail 444together in this position. The binder 446 is then slid onto the firstrail 442 and the second rail 444 to secure the closure. Optionally, theexcess length of the alignment cords 448 may be removed at this time.FIG. 74 is an enlarged view of the surgical closure device 440 of FIGS.73A-73E in the closed position.

Other surgeries that require a large incision or any incision that mightleave a visible scar would also benefit from the use of such a device,including laparotomy, thoracotomy, cesarean section, facelift, andbreast implant surgery.

One of the challenges in closing large incisions, such as thoseencountered during removal of redundant skin in bariatric patients, isthe prevention of “dog ears” in the closed incision. Dog ears occur whenone side of the incision is longer than the other or when one side ofthe incision is inadvertently stretched while closing the incision. Ifcare is not taken to make sure that the additional length of the longerside is evenly distributed along the shorter side during apposition andsuturing, the skin will bunch up along one side of the incision andpucker out in a shape that sometimes resembles a dog's ear. For goodcosmetic results, the sutures must be undone and the incision must beresutured. It can be very time consuming for the surgeon to correct thismistake.

The surgical closure device of the present invention can be very helpfulin preventing the occurrence of dog ears. One approach is to make therails of the surgical closure device in multiple segments along one orboth sides of the closure. Spaces between the segments along the longerside of the incision can be compressed to provide even distribution ofthe additional length of skin along the shorter side during apposition.The pull cords described above can be used to assure even appositionbetween the two sides of the incision during closure of the device.Alternatively or in addition, longitudinal pull cords may be providedalong one or both sides of the surgical closure device. The longitudinalpull cord on the longer side of the incision can be pulled to shortenthe longer side of the incision evenly prior to apposition and closureof the device. Optionally, the segments along the longer side of theincision can be made shorter than the segments on the shorter side tofacilitate even apposition. Another approach is to deliberately stretchthe skin on the shorter side of the incision prior to applying theadhesive patches of the surgical closure device to the patient's skin.This will assure even apposition and closure of the incision when thebinder is applied to the surgical closure device.

The surgical closure device can be made in one or more standardconfigurations based on common incision geometries. Alternatively, thesurgical closure device can be customized based an individual patient'smeasurements. FIG. 75 shows a low-profile embodiment of a surgicalclosure device 460 that will be more comfortable and less conspicuousfor patients to wear. The surgical closure device 460 has a firstadhesion patch 462 with a first rail 472 attached and a second adhesionpatch 464 with a second rail 474 attached. Optionally, the first andsecond adhesion patches 472, 474 may be joined together beyond the endsof the rails 472, 474 as shown. Preferably, the adhesion patches 462,464 are made from a breathable and flexible material, such as a flexiblefabric or a perforated flexible polymer sheet (optionally reinforced),with a contact adhesive applied to the underside. Optionally, the firstand second adhesion patches 472, 474 may be made from or coated with ahydrophobic material to resist absorbing or being stained by thepatient's blood. A flexible binder 466 is sized and configured to slideover the rails 472, 474 to bind the first adhesion patch 462 and thesecond adhesion patch 464 together.

FIG. 76 is a cross section of the low-profile surgical closure device460 of FIG. 75. An incision plane 468 is defined between the first rail472 and the second rail 474. Optionally, the surgical closure device 460may be cut through at the incision plane 468 between the first andsecond adhesion patches 462, 464 or it may be intact so that the surgeonwill cut through it at the time of making the skin incision.Alternatively, the surgical closure device 460 may be perforated orpartially cut through at the incision plane 468. The first rail 472 andthe second rail 474 are preferably U-shaped or J-shaped in cross sectionand positioned with their bends adjacent to the incision plane 468.Preferably, the first rail 472 and the second rail 474 are made of ametal, for example stainless steel, that has been cut or etched with apattern of slots 470 to make it flexible, while retaining the strengthof the U-shaped or J-shaped configuration. Examples of possible slot 470geometries are shown in close-up drawings in FIGS. 77, 78 and 79. Theflexible binder 466 is preferably C-shaped in cross section for a closefit around the first rail 472 and the second rail 474. Preferably, theflexible binder 466 is made of a metal, for example stainless steel,that has been cut or etched with a pattern of slots 476 to make itflexible, while retaining the strength of the C-shaped configuration.Examples of possible slot 476 geometries are shown in close-up drawingsin FIGS. 78 and 79. Optionally, the flexible binder 466 may be coveredor coated with a flexible polymer with a low coefficient of friction.Optionally, the flexible binder 466 may have a break-off handle 478 (SeeFIG. 75) that can be removed to minimized the profile of the device 460after the binder 466 has been installed. FIG. 78 illustrates an optionalfeature of the low-profile surgical closure device 460 of FIG. 75. Anend of the rails 472, 474 and/or an end of the flexible binder 466 maybe formed with a tapered configuration to facilitate insertion of therails 472, 474 into the binder 466.

FIGS. 79-80 illustrate another optional feature of the low-profilesurgical closure device 460 of FIG. 75. The rails 472, 474 and theflexible binder 466 may be formed with interlocking features that willsecurely lock the binder 466 to the rails 472, 474 once it has beeninstalled. In the example shown, the interlocking features include apair of tabs 480 formed on the end of the flexible binder 466 thatinterlock with a pair of spring detents 482 formed on the ends of therails 472, 474.

FIGS. 81-86 illustrate another low-profile embodiment of a surgicalclosure device 490. As shown in FIG. 82, the surgical closure device 490has a first adhesion patch 492 and a second adhesion patch 494 that meetalong an opening 493 that defines an incision line. The first adhesionpatch 492 and the second adhesion patch 494 may be separate or,optionally, may be joined together beyond the ends of the opening 493. Afirst sleeve 496 is connected to the first adhesion patch 492 along oneedge of the opening 493 and a second sleeve 498 is connected to thesecond adhesion patch 494 along the opposite edge of the opening 493.Preferably, the first adhesion patch 492, the first sleeve 496, thesecond adhesion patch 494 and the second sleeve 498 are made of aflexible, breathable fabric. The sleeves 496, 498, which are shown incross section in FIG. 83, can be formed by adhesive bonding, sewing orwelding the fabric. The sleeves 496, 498 may be continuous, as shown, orthey may be configured in intermittent segments to make the surgicalclosure device 490 more flexible.

The sleeves 496, 498 of the surgical closure device 490 serve the samefunction as the rails in other embodiments described herein. Thefunction of the binder is served by an elongated fork-shaped binder 500,shown in FIG. 84, having a first tine 502 and a second tine 504 that areconfigured for a sliding fit within the first and second sleeves 496,498, respectively. The first tine 502 and the second tine 504 of thefork-shaped binder 500 are attached at one end by a cross member 503.The fork-shaped binder 500 is preferably formed of a metal, such asstainless steel, nickel-titanium or other suitable alloy by any suitableprocess, such as machining, stamping, photoetching, etc. Alternatively,the fork-shaped binder 500 may be formed of a rigid polymer or afiber-reinforced polymer composite. In one particularly preferredembodiment, the fork-shaped binder 500 is configured with apartially-open section 506 where the first tine 502 and the second tine504 are spaced apart by a small gap 505 and a closed section 508 wherethe first tine 502 and the second tine 504 are side-by-side with littleor no gap in between. Additionally, there may be an end section 507where the first tine 502 and the second tine 504 are tapered tofacilitate insertion into the first and second sleeves 496, 498.Optionally, there may be a cover seal 510 attached to the fork-shapedbinder 500. The cover seal 510 may be made from the same material as thefork-shaped binder 500 or a different material.

In use, the surgical closure device 490 is adhered to the patient's skinwith a contact adhesive on the underside of the first adhesion patch 492and the second adhesion patch 494. The closed section 508 of thefork-shaped binder 500 is positioned within the first and second sleeves496, 498 to hold the surgical closure device 490 in a closed position,as shown in FIG. 81. Next, the fork-shaped binder 500 is slidlongitudinally so that the partially open section 506 of the fork-shapedbinder 500 is positioned within the first and second sleeves 496, 498 tohold the surgical closure device 490 in a partially open position. Whilethe surgical closure device 490 in the partially open position, anincision is made in the skin through the opening 493 formed between thefirst adhesion patch 492 and the second adhesion patch 494. After theincision is made, the fork-shaped binder 500 may be temporarily removedfrom the first and second sleeves 496, 498 to allow the opening 493 andthe tissue below to be retracted for performing surgery through theincision. After the surgery has been completed, the fork-shaped binder500 is reinserted and moved to the closed position to close the opening493 between the first adhesion patch 492 and the second adhesion patch494. The tissue will be precisely apposed in the same position as beforethe surgery. Optionally, the fork-shaped binder 500 may apply acompressive force on the incision in the dosed position. The sections506, 507 of the fork-shaped binder 500 that are no longer needed arepreferably removed by bending the tines 502, 504 upward and breakingthem off at a score line 509 on the underside of the tines 502, 504 or,alternatively, by cutting the tines 502, 504 off with a cutting device.Next, the cover seal 510 is folded over the first and second sleeves496, 498 and the closed section of the fork-shaped binder 500 to lockand seal the surgical closure device 490 in the closed position, asshown in FIGS. 85-86. Optionally, the cover seal 510 may have a pair oflocking pins 512 that interlock with a pair of holes 514 in the firstand second tines 502, 504 to secure the fork-shaped binder 500 in theclosed position. Alternatively or in addition, the cover seal 510 mayhave a contact adhesive to lock and seal the surgical closure device 490in the dosed position.

FIG. 87 illustrates an optional incision template 590 that can be usedwith the surgical closure device 490 in FIGS. 81-86. The incisiontemplate 590 fits over the surgical closure device 490 when it is in aclosed or partially-open position. A central slot 592 hasdownwardly-extending lips 594 that extend into the opening 493 toprotect the first sleeve 496 and the second sleeve 498 from being cutwhen the incision is being made. The incision template 590 is preferablymade of a rigid or semi-rigid polymer or metal that will resist beingcut by a scalpel or other cutting device. The incision template 590 isalso adaptable for use with other embodiments of the surgical closuredevice described herein.

FIG. 88 illustrates a variation of the fork-shaped binder 500 that hasan inwardly convex, arcuate or bowed curvature to the tines 502, 504 sothat, when the fork-shaped binder 500 is locked in a closed position, anincreased closing pressure is applied over the center of the incision.

FIG. 89 illustrates a variation of the fork-shaped binder 500 thatserves a similar function to the partially-open section 506 of thefork-shaped binder 500 shown in FIG. 84. This variation of thefork-shaped binder 500 has a gap 505 between the tines 502, 504 to applya spreading force to the opening 493 in the surgical closure device 490and to the skin underneath to facilitate making an incision through theopening 493.

FIG. 90 illustrates a variation of the fork-shaped binder 500 that isconfigured to lift the tissue adjacent to the incision when the surgicalclosure device 490 is in a closed position. The first tine 502 and thesecond tine 504 are angled upward so that, when the fork-shaped binder500 is inserted into the first sleeve 496 and the second sleeve 498, thetissue adjacent to the incision is lifted up. Lifting the tissueadjacent to the incision is intended to reduce subsidence or retractionof the tissue that frequently occurs during the healing process. Thisshould result in reduced scar formation and improved cosmesis.Similarly, other styles of binders that are described herein can also beconfigured to lift the tissue adjacent to the incision when the surgicalclosure device is in a closed position.

FIG. 91 shows another optional feature that can be used to raise thetissue adjacent to the incision when the surgical closure device is in aclosed position. An adhesive protective cover 600 has a tent-likestructure 602 that can be applied along the incision line to raise thetissue adjacent to the incision. The tent-like structure 602 may be madeof a polymer or metal of sufficient stiffness to raise the tissueadjacent to the incision. The protective cover 600 can be applied at thetime the incision is closed or may be applied later after initialhealing has taken place. For example, once initial healing has takenplace, the binder can be removed and the protective cover 600 can beapplied over the surgical closure device. Optionally, the tent-likestructure 602 may be made of a material that is resilient enough that itcan be flattened to apply it over the surgical closure device using acontact adhesive. Then, when it is released, the elastic resilience ofthe tent-like structure 602 lifts the tissue adjacent to the incision.

FIGS. 92, 93 and 94 illustrate another variation of the surgical closuredevice 490 of FIGS. 81-86 that utilizes first and second fork-shapedbinders 500, 501 that are inserted from opposite ends of the first andsecond sleeves 496, 498 to hold the surgical closure device 490 in aclosed position. FIG. 92 shows the surgical closure device 490 prior toinsertion of the first and second fork-shaped binders 500, 501 and FIG.93 shows the surgical closure device 490 in the closed position, afterinsertion of the first and second fork-shaped binders 500, 501. Usingtwo fork-shaped hinders 500, 501 provides additional security to thesurgical closure device 490 in the closed position. Optionally, thefirst and second fork-shaped binders 500, 501 may fit togethertelescopically, as shown in FIG. 94, and/or may have locking features tolock the first and second fork-shaped binders 500, 501 together.

The first and second fork-shaped binders 500, 501 can also be used toprovide a surgical closure device 490 with customizable length. Thefirst adhesion patch 492 and the second adhesion patch 494 may be cut tothe desired length to fit the intended incision or an existing incisionor wound. A fork-shaped binder 500 of the appropriate length may beinserted into the cut ends of sleeves 496, 498 to hold the cut end ofthe opening 493 together. If desired, the first and second fork-shapedbinders 500, 501 may be different lengths. For example, a very shortfirst fork-shaped binder 500 may be just long enough to hold the cut endof the of sleeves 496, 498 and opening 493 together until the secondfork-shaped binder 501 is inserted to close the incision.

FIGS. 95-96 illustrate additional features that may be used with thesurgical closure device 490 in FIGS. 81-86. A drug injection manifold520 has a main tube 516 with a proximal connector 522, such as a Luerfitting, and a closed distal end 517. At least one, and preferablyseveral, drug injection needles or catheters 518 are connect to the maintube 516. As shown in the exploded view in FIG. 95, the fork-shapedbinder 500 has a series of holes 524 that allow the drug injectionneedles or catheters 518 to be inserted into the incision while thesurgical closure device 490 is in the closed position. FIG. 96 alsoillustrates that the fork-shaped binder 500 may be shortened so that itonly includes the closed section 506 and optionally, a tapered endsection 507. Optionally, the drug injection manifold 520 may alsoinclude a contact adhesive and/or locking pins or other locking featuresto seal and secure the surgical closure device 490 in the closedposition. The drug injection manifold 520 may be inserted while thewound is still open or after the surgical closure device 490 has beenclosed, as shown in FIG. 96.

FIG. 97 illustrates another variation of the drug injection manifold520, wherein the drug injection needles or catheters 518 are curvedalternately to the left and right so that a drug, such as an anesthetic,will be injected into the tissue on both sides of the incision.

FIGS. 98-99 illustrate an optional feature that may be used with any ofthe embodiments of the surgical closure device described herein. Animpermeable and/or hydrophobic protective cover 530 is applied over thesurgical closure device 490 to protect it from absorbing and/or beingstained by blood or other contaminants during use. The protective cover530 may be clear, translucent or opaque. During manufacturing, theprotective cover 530 may be folded onto the upper surface of thesurgical closure device 490, as shown in FIG. 98, so that it can beunfolded to cover a larger area in use, as shown in FIG. 99. Theprotective cover 530 is preferably adhered to the surgical closuredevice 490 and the patient's skin with a weak contact adhesive so thatit can be removed after surgery to leave a clean surface underneathwithout discomfort to the patient or danger of moving or dislodging thesurgical closure device 490.

FIGS. 100-105 illustrate another embodiment of a surgical closure device540 configured for making and closing a shaped incision in the patient'sskin, such as a wedge biopsy incision. The surgical closure device 540is similar in many respects to the embodiments of FIGS. 16 and 62. Thereis a nonlinear shaped opening 548 between the first adhesion patch 542and the second adhesion patch 544 that defines the shape of theincision. in one particularly preferred embodiment, the shaped opening548 has the geometry of an ellipse or a rounded lozenge shape somewhatlike the shape of an American football or a convex-convex lens. A firstsleeve 552 and a second sleeve 554 follow the outline of the shapedopening 548. Preferably, the first and second adhesion patches 542, 544are joined together beyond the ends of the shaped opening 548. The firstadhesion patch 542, the second adhesion patch 544, the first sleeve 552and the second sleeve 554 are made of flexible materials that allow theshaped opening 548 to move from an open position to a closed position.Optionally, the shaped opening 548 may be biased toward the openposition or the closed position.

Positioned within the shaped opening 548, when the surgical closuredevice 540 is in an open position as shown in FIG. 100, is an incisiontemplate 556 that follows the contours of the shaped opening 548 andprotects the surgical closure device 540 from being accidentally cutwhen the incision is being made. The incision template 556 may alsoserve to hold the shaped opening 548 in the open position inside of theincision template 556 is a shaped insert 558 that has approximately thesame shape as the shaped opening 548 and a spacer 560 between theincision template 556 and the shaped insert 558. There is a spacerhandle 561 attached to the spacer 560 and an insert handle 559 attachedto the shaped insert 558. In one particularly preferred embodiment, thespacer handle 561 is shaped somewhat like a joystick controller. Theshaped insert 558 has a contact adhesive on its lower surface 562.Alternatively or in addition, the shaped insert 558 can have hooks,barbs, forceps jaws, suction cups or other means on the lower surface562 for gripping the patient's skin.

In use, the surgical closure device 540 is adhered to the patient's skinwith contact adhesive on the first adhesion patch 542, the secondadhesion patch 544 and the shaped insert 558, as shown in FIG. 100.Preferably, the shaped insert 558 is somewhat transparent so that thesurgical closure device 540 can be accurately positioned with the shapedopening 548 around a suspected lesion. Then, the spacer 560 is liftedout using the spacer handle 561, as shown in FIG. 101, leaving a narrowgap 564 between the incision template 556 and the shaped insert 558sufficient for insertion of a scalpel blade or other cutting instrument.Using the insert handle 559 on the shaped insert 558, the surgeon canlift and tension the skin to facilitate making an incision and enablecutting the bottom of the biopsy sample to be removed. The biopsy samplecan be manipulated while making the incision and conveniently lifted outusing the insert handle 559 after the incision is made, as shown in FIG.102.

In an alternative configuration, the shaped insert 558 could also have acutting blade along the lower edge, like a cookie cutter or a punchbiopsy device, to cut the skin and tissue around the biopsy sample to beremoved. Optionally, the shaped insert 558 may include one or moreindicia 566 to indicate the orientation of the biopsy sample. Theindicia 566 may indicate the orientation of the biopsy sample withrespect to the patient's anatomy (e.g. “S” for “superior”) and/or one ormore corresponding indicia may be provided on the surgical closuredevice 540. Alternatively, one or more indicia may be provided forattachment directly to the biopsy sample, for example using contactadhesive.

Next, the incision template 556 is removed and a fork-shaped binder 566is inserted into the first sleeve 552 and the second sleeve 554 to closethe shaped opening 548, as shown in FIG. 103. Optionally, a seal stripand/or a drug infusion manifold may be used with the surgical closuredevice 540.

Optionally, the surgical closure device 540 may include a protectivecover 568 that can be applied over the opening 548 with a contactadhesive after the incision has been closed, as shown in FIGS. 104-105.The protective cover 568 will seal the surgical closure device 540against potential contamination and will add strength to the closure.Optionally, the fork-shaped binder 566 may be removed after theprotective cover 568 has been applied or after an initial period ofhealing has taken place. The surgical closure device 540 will be moreflexible and more comfortable for the patient after the binder 566 hasbeen removed. FIG. 104 shows the protective cover 568 in apartially-closed position with the ends 569 lifted to allow access tothe ends of the fork-shaped binder 566 for easy removal of the binder566 while securing the surgical closure device 540 in a closed position.After the binder 566 has been removed, the ends 569 of the protectivecover 568 are adhered down to fully seal the surgical closure device540, as shown in FIG. 105.

FIGS. 106-107 illustrate another embodiment of a low-profile surgicalclosure device 570. The surgical closure device 570 has a first adhesionpatch 572 and a second adhesion patch 574 that meet along an opening 573that defines an incision line. The first adhesion patch 572 and thesecond adhesion patch 574 are joined together beyond the ends of theopening 573. An internal slot 578 extends through the surgical closuredevice 570 below the opening 573. An internal binder 580 is sized andconfigured to slide into the internal slot 578 to bind the firstadhesion patch 572 and a second adhesion patch 574 together when in theclosed position, as shown in FIG. 106. Preferably, the internal slot 578is formed with undercuts 582 that interlock with corresponding ridges584 on the internal binder 580, as shown in the close-up view in FIG.107.

Optionally, the internal binder 580 may be made with a partially-openportion 586 with an incision guide slot 588 along the centerline. Thepartially-open portion 586 is somewhat wider than the remainder of theinternal binder 580 so that, when it is positioned within the internalslot 578, it stretches the opening 573 and the skin beneath the opening573 in order to facilitate making an incision through the incision guideslot 588. The partially-open portion 586 may be, broken off or cut offof the internal binder 580 after the surgical closure device 570 hasbeen closed.

The surgical closure device 570 of FIGS. 106-107 may also be used forapplying a surgical adhesive (e.g. a cyanoacrylate, fibrin, albumin orglutaraldehyde based adhesive) for closure of the skin incision aftersurgery. The surgical closure device 570 and the internal binder 580would be made of or coated with a material, such as PTFE or HDPE, thatdoes not bond with the surgical adhesive. With the partially-openportion 586 of the internal binder 580 positioned within the internalslot 578, the incision would be spread open with a predetermined gap sothat a metered amount surgical adhesive could be applied. Then, theinternal binder 580 would be moved to the closed position to close theincision. Optionally, the internal binder 580 may be removed after thesurgical adhesive has cured.

As mentioned previously, the surgical closure device of the presentinvention may be configured as a single device that extends the entirelength of the incision or, alternatively, the device may be modular andmade up of either separate or interconnected segments. A modularsurgical closure device would be particularly useful for closing longincisions, such as those used for surgical removal of redundant skinfollowing successful bariatric surgery.

One method of interconnecting modular segments is with modular bindersthat connect end-to-end. FIGS. 108-109 illustrate an elongated surgicalclosure device 620 that uses modular fork-shaped binders 630 to close anelongated incision. FIG. 109 shows an elongated surgical closure device620 that has a first adhesion patch 622 and a second adhesion patch 624with a first sleeve 626 and a second sleeve 628 positioned alongadjacent edges of the first adhesion patch 622 and the second adhesionpatch 624. In one particularly preferred embodiment, the first sleeve626 and the second sleeve 628 are segmented to allow the first adhesionpatch 622 and the second adhesion patch 624 to be very flexible so thatit can be placed along a curving or irregular incision line on thepatient. The first adhesion patch 622 and the second adhesion patch 624may be long enough to surround the entire circumference of the patientor multiple shorter adhesion patches 622, 624 may be adhered to the skinend-to-end along the intended incision lines.

After excision of the redundant skin between the first adhesion patch622 and the second adhesion patch 624, the first sleeve 626 and thesecond sleeve 628 are brought into close alignment with one another.Then, the tines 632, 634 of a fork-shaped binder 630 are insertedthrough the sleeves 626, 628 to close a first segment of the incision.The tines 632, 634 of another fork-shaped binder 630 are insertedthrough the sleeves 626, 628 to close a second segment of the incision,and so on until the entire length of the incision has been closed, asshown in FIG. 109. Optionally, each of the fork-shaped binders 630 mayhave a T-shaped head 636 with a slot 638 for inserting the ends of thetines 632, 634 of the adjacent fork-shaped binder 630 so that thefork-shaped binders 630 will be linked together end-to-end. Optionally,each of the slots 638 may have a ratchet pawl or other locking mechanismto lock the fork-shaped binders 630 together in the end-to-endconfiguration. If the first adhesion patch 622 and the second adhesionpatch 624 are also modular, that is made in short segments laidend-to-end, then the fork-shaped binders 630 should bridge the gaps 640between adjacent adhesion patches, as shown in FIG. 109. The gaps 640between adjacent adhesion patches can be closed by applying tension onthe ends of the fork-shaped binders 630.

Additional features may be combined with any of the surgical closuredevices disclosed herein:

Optionally, the rails and the binder of the surgical closure device maybe configured to provide a small amount of compression at the incisionin the closed position such that the edges of the incision turn upwardslightly. This technique may provide better healing of the incision insome circumstances.

Optionally, the binder may be made with lateral reinforcements thatprovide additional strength for secure closure. The lateralreinforcements may be U-shaped or C-shaped and embedded in or wrappedaround a flexible polymer channel to provide lateral strength whileallowing the binder to be very flexible. The lateral reinforcements maybe made of metal, such as stainless steel, or rigid plastic or a fiberreinforced composite. The lateral reinforcements may also be constructedas a continuous wire form that is provides lateral strength, but allowsflexibility of the binder. The wire form could be configured as aserpentine or wave-like formation that is embedded in or wrapped aroundthe binder channel in U-shaped or C-shaped cross section.

The surgical closure device of the present invention can also becombined with other wound healing modalities, for example hyperbaricoxygen therapy, suction therapy, stem cell implantation, wound drainage,etc. Oxygen can be supplied to the surgical closure device by hydrolysisusing a small reservoir of water and a battery within the device orconnected to it.

While the present invention has been described herein with respect tothe exemplary embodiments and the best mode for practicing theinvention, it will be apparent to one of ordinary in the art that manymodifications, improvements and subcombinations of the various featuresand embodiments, adaptations and variations can be made to the inventionwithout departing from the spirit and scope thereof.

1. A wound closure device, comprising: a first adhesion patch configuredfor adhering to a patient's skin; a second adhesion patch configured foradhering to the patient's skin; the wound closure device having an openposition with an approximately elliptical shaped opening formed betweenthe first adhesion patch and the second adhesion patch and a closedposition wherein the first adhesion patch and the second adhesion patchare held in close proximity to each other.
 2. The wound closure deviceof claim 1, wherein the first adhesion patch is joined to the secondadhesion patch at end portions beyond the opening between the firstadhesion patch and the second adhesion patch.
 3. The wound closuredevice of claim 1, further comprising: a closed binder for holding thewound closure device in the closed position.
 4. The wound closure deviceof claim 3, further comprising: an open binder for holding the woundclosure device in the open position.
 5. The wound closure device ofclaim 4, wherein the open binder has a central opening having an inneredge configured as an incision guide.
 6. The wound closure device ofclaim 1, further comprising: a shaped insert insertable into the openingbetween the first adhesion patch wherein the shaped insert holds thewound closure device in the open position.
 7. The wound closure deviceof claim 6, further comprising: a removable spacer between the shapedinsert and the opening between the first adhesion patch and the secondadhesion patch.
 8. The wound closure device of claim 6, wherein theshaped insert has a skin contact surface with a contact adhesive foradhering to the patient's skin and an upper surface with a handle formanipulating the shaped insert.
 9. The wound closure device of claim 6,wherein the shaped insert has a skin contact surface with means forattaching to the patient's skin and an upper surface with a handle formanipulating the shaped insert.
 10. The wound closure device of claim 1,wherein the shaped insert includes an indicium for indicating anorientation of the shaped insert with respect to the patient's body. 11.A method for surgical removal of biopsy tissue from skin on a patient,said method comprising: adhering a first adhesion patch to the patient'sskin along a first intended incision line; adhering a second adhesionpatch to the patient's skin along a second intended incision line spacedapart from the first intended incision line; excising the biopsy tissueof the patient's skin between the first intended incision line and thesecond intended incision line; and binding the first adhesion patch tothe second adhesion patch to close the patient's skin between the firstintended incision line and the second intended incision line.
 12. Amethod as in claim 11, wherein the incision lines define an ellipticalregion on the patient's skin.
 13. A method as in claim 12, wherein theskin and tissue are excised along the intended excision lines.
 14. Amethod as in claim 11, wherein binding comprises initially holding thefirst and second adhesion patches apart using an open binder and closingthe adhesion patches with a closed binder.
 15. A method as in claim 11,wherein the first and second patches are initially attached together bya removal spacer between their inner edges, further comprising holdingthe patches with the spacer, placing the patches on the skin whileholding the spacer, and removing the spacer to expose skin between theincision lines.